Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System.
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- spatial coordinates of the target (3 translations and 3 rotations)
研究概览
简要总结
The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system).
详细描述
For the past 10 years, the use of computer-assisted surgery has expanded and is now widely spread in the orthopaedic domain, but not in maxillary-facial surgery. The main disadvantages of this technique are the necessity to fix a mark on the eyebrow with two transcutaneous pins, which is a long and invasive act, and to connect the infrared transmitter which is in contact with the patient with the computer in a limited surgery area. In this study, we want to show that the new repositioning optic systems are performing similarly to the actual validated one, that they permit to suppress the transcutaneous pins and the computer connection, and that it reduces the financial cost of this surgery. Neither the surgery technique, nor the pre-operative check-up will be modified in the study. The two repositioning systems will be used simultaneously during the mandibular osteotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mandibular orthognathic surgery
排除标准
- •Age <18 years
结局指标
主要结局
spatial coordinates of the target (3 translations and 3 rotations)
时间窗: during surgery
次要结局
- time to install the eyebrow mark with each technique.(during surgery)
- adverse events due to the transcutaneous pins.(during surgery)
- number of handling realized by the nurse for each technique.(during surgery)
- evaluation of cost: number of cable versus number of marker.(during surgery)